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Patient-Reported Outcomes in Performance Measurement Patient-Reported Outcomes in Performance Measurement David Cella, Elizabeth A. Hahn, Sally E. Jensen, Zeeshan Butt, Cindy J. Nowinski, Nan Rothrock, Kathleen N. Lohr Patient-Reported Outcomes in Performance Measurement David Cella, Elizabeth A. Hahn, Sally E. Jensen, Zeeshan Butt, Cindy J. Nowinski, Nan Rothrock, Kathleen N. Lohr RTI Press ©2015 Research Triangle Institute. RTI International The RTI Press mission is to disseminate is a registered trademark and a trade name of information about RTI research, analytic Research Triangle Institute. The RTI logo is a tools, and technical expertise to a national registered trademark of Research Triangle Institute. and international audience. RTI Press publications are peer-reviewed by at least This work is distributed under the two independent substantive experts and terms of a Creative Commons one or more Press editors. Attribution-NonCommercial-NoDerivatives 4.0 license (CC BY-NC-ND), a copy of which is RTI International is an independent, available at https://creativecommons.org/licenses/ nonprofit research institute dedicated by-nc-nd/4.0/legalcode. to improving the human condition. We combine scientific rigor and technical Any views or opinions presented in this book are expertise in social and laboratory solely those of the authors and do not necessarily sciences, engineering, and international represent those of RTI International or Northwestern development to deliver solutions to the University Feinberg School of Medicine. critical needs of clients worldwide. Library of Congress Control Number: 2015948921 ISBN 978-1-934831-14-4 (refers to printed version) RTI Press publication No. BK-0014-1509 https://doi.org/10.3768/rtipress.2015.bk.0014.1509 This publication is part of the RTI Press Book series. RTI International 3040 East Cornwallis Road, PO Box 12194 Research Triangle Park, NC 27709-2194 USA [email protected] www.rti.org Contents Introduction 1 The National Quality Forum Project 2 Concepts and Definitions 3 Types of Patient-Reported Outcomes 7 Health-Related Quality of Life 8 Functional Status 9 Symptoms and Symptom Burden 9 Health Behaviors 10 Patient Experience of Care 11 Method and Mode of Administration, Data Collection, and Analysis 15 Modes and Methods Issues 17 Mode: Self-Administration Versus Interviewer Administration 20 Method of Administration 21 Patient-Reported Outcome Measures in the Clinical Setting 23 Scoring: Classical Test Theory Versus Modern Test Theory 26 Linking or Cross-Talk Between Different Measures of the Same Construct 27 Addressing Barriers to Patient-Reported Outcomes Measurement 28 Vulnerable Populations 28 Literacy 29 Language and Culture 30 Functional Abilities 31 Response Shift, Adaptation, and Other Challenges to Detecting True Change 33 Implications of the Different Methods and Modes for Response Rate, Reliability, and Validity 34 Implementing Data Collection Methods 34 Using Different Method or Mode Than the One Originally Validated 34 Using Multiple Methods and Modes 35 Accounting for the Impact of Nonresponders 35 Selection of Patient-Level PROMs 36 Patient-Centered Outcomes Research 36 Attributes of PROMs 37 (continued) iv Contents (continued) Important Differences in PROM Attributes 42 Instrument Length 42 Implications of PRO Data for Action 43 History of Successful Use of PROMs 43 Documentation of Particular Attributes of PROMs 44 PROM Characteristics for Consideration 45 Generic Versus Condition-Specific Measures 45 Measurement Precision 47 Sensitivity to Change, or Responsiveness 47 Minimally Important Differences 49 Essential Conditions to Integrate PROMs Into the Electronic Health Record 51 General Considerations for Health Information Technology 51 Examples of PROMs in Electronic Health Record Applications 53 Selection of PROMs That Meet Recommended Characteristics for Use in Performance Measures 55 Conclusions 57 References 59 Acknowledgments 93 About the Authors 95 Tables Table 1. Definitions and key concepts for patient-reported outcomes and measures 4 Table 2. Main characteristics of patient-reported outcomes 7 Table 3. PRO methods: characteristics, strengths, and limitations 15 Table 4. Primary criteria for evaluating and selecting patient-reported outcome measures (PROMs) for use in performance measurement 38 Figure Figure 1. Types of respondent sources of data and modes and methods of administration 18 Introduction The increasing integration of health care delivery systems provides an opportunity to manage entire episodes of care in a patient-focused manner and to assess the impact of care on patient outcomes, including patient-reported outcomes (PROs).1 The National Institutes of Health (NIH) PROMIS initiative (for Patient Reported Outcomes Measurement Information System) describes PROs as direct feedback from patients “on their feelings or what they are able to do as they are dealing with chronic diseases or conditions.” They reflect the health status or health-related quality of life circumstances of patients (broadly defined). Such information is reported by individuals themselves or, in some cases, by proxy respondents such as parents for young children or close relatives of persons unable to report for themselves. PRO information is widely gathered in clinical and health services research; it is increasingly collected and used in clinical practice settings as well.2–7 PROs are relevant for many activities: helping patients and their clinicians make informed decisions about health care, monitoring the progress of care, setting policies for coverage and reimbursement of health services, improving the quality of health care services, and tracking or reporting on the performance of health care delivery organizations. These last two activities are gaining increasing attention in the US health care system. The nation is engaging in more efforts to expand health care coverage to many millions of citizens through the Patient Protection and Affordable Care Act (ACA). Many organizations are working to ensure higher value of health care through enhanced attention to measuring and improving quality of care and patient outcomes.8 For example, the Patient-Centered Outcomes Research Institute (PCORI), established by the ACA, is actively pursuing ways to increase the use of PROs for clinical care, research, and performance assessment. 2 Patient-Reported Outcomes in Performance Measurement The National Quality Forum Project The National Quality Forum (NQF), a national organization that has been deeply involved in moving the quality-improvement agenda forward for many years (http://www.qualityforum.org), endorses and promulgates quality-of- care and performance measures that various provider groups, regulatory agencies, payers and insurers, and others can use for accountability and quality improvement activities. In 2012 and 2013, the organization began an initiative to find PROs that might be added to its extensive collection of performance measures. Its National Voluntary Consensus Standards for Patient Outcomes: A Consensus Report defined outcomes as being important because they “reflect the reason that an individual seeks healthcare services.”1 The individual patient’s voice in many performance measures, however, has largely been missing. Few ways to assess performance are available at the organizational level, even though patients are often the best able to report on the experiences and results of their individual care. To fill that gap, NQF convened an expert panel at two public meetings and, as background for its deliberations, commissioned two authoritative background papers. This monograph is a revised and updated version of the first of these two papers, which provided the background on issues about selecting PROs for use in a variety of applications pertinent to the NQF mission and activities. The second paper, Patient-Reported Outcomes in Performance Measurement,9 dealt with issues relating to processes for endorsing performance measures that reflect the end results (ultimate outcomes) of health care. Its primary focus was on accountable health care organizations. This monograph applies the conceptual and organizational frameworks that NQF has pioneered in the past decade or so. NQF distinguishes PROs, patient- reported outcome measures (or PROMs), and patient-reported outcome performance measures (or PRO-PMs). NQF endorses PRO-PMs through transparent and consensus-based procedures. This monograph addresses the PROs that are likely to be used to inform PRO measures (PROMs) that would underpin scientifically acceptable and feasible performance measures. We do not address issues with identifying, evaluating, or endorsing PRO-PMs for health care organizations or clinicians. Introduction 3 To accomplish our assigned objective, we completed a comprehensive review of the published peer-reviewed literature as well as published documents (e.g., book chapters, position statements; guidance from the US Food and Drug Administration10) about standard measurement theory. Based on our findings in the published literature, we created a comprehensive annotated outline reflecting the methodological considerations most important to address. We then revised it in consultation with representatives from NQF to ensure that the paper accomplished the NQF’s high-priority objectives. Following the initial drafting of the manuscript, our group of authors at Northwestern University worked in conjunction with Kathleen Lohr, RTI International, who comprehensively reviewed and revised the manuscript draft. We submitted the revised manuscript
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